Harini Devi
Associate II, RDCM | Regulatory Sciences| CMC| RIMS| Data Maintenance
- Role
- Regulatory Data Conformance Management - Associate Ii at 화이자
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Harini Devi
With a strong passion for regulatory affairs, compliance and process excellence, I thrive…
Experience
Regulatory Data Conformance Management - Associate Ii
Aug 2023 — Present · Chennai, IN
Liase with stakeholders for continuous improvement/updates of regulatory standards, process and maintain documented procedures and guidelines specific to each region.Demonstrate comprehensive knowledge of regulatory requirements and regulations, collaborating with GRS on complex updates.Maintain HA status in dossier management system for defined region.Track regulatory submissions for clinical and investigational products from planning, submission through final HA regulatory status.Liase with regulatory, manufacturing and other parties as appropriate to ensure product information is updated and maintained in accordance with product license.Adhering to quality control procedures and standards ensuring regulatory compliance.Compliant with inspection readiness activities, maintaining high standards of regulatory preparedness for internal and external audits.
Education
Sethu Bhaskara Matriculation Higher Secondary School
Biology, General
Rajalakshmi Engineering College
Bachelor of Engineering - BE
2019 — 2023
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